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Safety and Tolerability Study of ARC-520 in Healthy Volunteers

Sponsor
Arrowhead Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01872065
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
16
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARC-520

Single dose, intravenous administration of ARC-520.

Drug: ARC-520
Placebo Comparator: Normal Saline

Single dose, intravenous administration of Normal Saline

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520 [One month]

    The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group.

Secondary Outcome Measures

  1. To evaluate the pharmacokinetics of ARC-520 at different dose concentrations [2 days]

    Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:

  • Healthy male or female subjects, 18-55 years of age

  • Be a non-smoker

Key Exclusion Criteria:

  • History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

  • Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination.

  • Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment.

  • Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.

  • Currently uses and/or has a history of alcohol and/or drug abuse < 12 months from screening.

  • Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nucleus Network Ltd. Melbourne Victoria Australia 3004

Sponsors and Collaborators

  • Arrowhead Pharmaceuticals

Investigators

  • Principal Investigator: Jason Lickliter, MD, PhD, Nucleus Network Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01872065
Other Study ID Numbers:
  • Heparc-1001
First Posted:
Jun 7, 2013
Last Update Posted:
Dec 10, 2014
Last Verified:
Dec 1, 2014

Study Results

No Results Posted as of Dec 10, 2014